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WO2008116601A3 - Solid dosage forms comprising aliskiren and pharmaceutically acceptable salts thereof - Google Patents

Solid dosage forms comprising aliskiren and pharmaceutically acceptable salts thereof Download PDF

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Publication number
WO2008116601A3
WO2008116601A3 PCT/EP2008/002257 EP2008002257W WO2008116601A3 WO 2008116601 A3 WO2008116601 A3 WO 2008116601A3 EP 2008002257 W EP2008002257 W EP 2008002257W WO 2008116601 A3 WO2008116601 A3 WO 2008116601A3
Authority
WO
WIPO (PCT)
Prior art keywords
aliskiren
pharmaceutically acceptable
solid dosage
acceptable salts
dosage forms
Prior art date
Application number
PCT/EP2008/002257
Other languages
French (fr)
Other versions
WO2008116601A2 (en
WO2008116601A4 (en
Inventor
Franc Vrecer
Vida Skrabanja
Natalija Zajc
Urska Gojak
Original Assignee
Krka Tovarna Zdravil D D Novo
Franc Vrecer
Vida Skrabanja
Natalija Zajc
Urska Gojak
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Krka Tovarna Zdravil D D Novo, Franc Vrecer, Vida Skrabanja, Natalija Zajc, Urska Gojak filed Critical Krka Tovarna Zdravil D D Novo
Priority to US12/532,621 priority Critical patent/US20100143460A1/en
Priority to EP08734694A priority patent/EP2136789A2/en
Priority to EA200901146A priority patent/EA020331B1/en
Publication of WO2008116601A2 publication Critical patent/WO2008116601A2/en
Publication of WO2008116601A3 publication Critical patent/WO2008116601A3/en
Publication of WO2008116601A4 publication Critical patent/WO2008116601A4/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/02—Non-specific cardiovascular stimulants, e.g. drugs for syncope, antihypotensives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Diabetes (AREA)
  • Epidemiology (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Hospice & Palliative Care (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

The present invention relates to a pharmaceutical formulation comprising aliskiren or a pharmaceutically acceptable salt thereof as the active ingredient, wherein the pharmaceutical formulation is present in a solid dosage form suitable for oral administration based on a granulate obtained by a hot-melt and solvent-free granulation process, and to a process for manufacturing a pharmaceutical formulation.
PCT/EP2008/002257 2007-03-23 2008-03-20 Solid dosage forms comprising aliskiren and pharmaceutically acceptable salts thereof WO2008116601A2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US12/532,621 US20100143460A1 (en) 2007-03-23 2008-03-20 Solid dosage forms comprising aliskiren and pharmaceutically acceptable salts thereof
EP08734694A EP2136789A2 (en) 2007-03-23 2008-03-20 Solid dosage forms comprising aliskiren and pharmaceutically acceptable salts thereof
EA200901146A EA020331B1 (en) 2007-03-23 2008-03-20 Process for manufacture of pharmaceutical formulation comprising aliskiren

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP07006055A EP1972335A1 (en) 2007-03-23 2007-03-23 Solid dosage forms comprising aliskiren and pharmaceutically acceptable salts thereof
EP07006055.3 2007-03-23

Publications (3)

Publication Number Publication Date
WO2008116601A2 WO2008116601A2 (en) 2008-10-02
WO2008116601A3 true WO2008116601A3 (en) 2009-07-23
WO2008116601A4 WO2008116601A4 (en) 2009-09-24

Family

ID=38006908

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2008/002257 WO2008116601A2 (en) 2007-03-23 2008-03-20 Solid dosage forms comprising aliskiren and pharmaceutically acceptable salts thereof

Country Status (5)

Country Link
US (1) US20100143460A1 (en)
EP (2) EP1972335A1 (en)
EA (1) EA020331B1 (en)
UA (1) UA96622C2 (en)
WO (1) WO2008116601A2 (en)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2548553A1 (en) * 2007-09-28 2013-01-23 Novartis AG Galenical formulations of aliskiren
CA2724320A1 (en) * 2008-06-06 2009-12-10 Teva Pharmaceutical Industries Ltd. Solid states of aliskiren free base
EP2143425A1 (en) * 2008-07-11 2010-01-13 Ratiopharm GmbH Directly pressed aliskiren tablets
AR073651A1 (en) * 2008-09-24 2010-11-24 Novartis Ag GALENIC FORMULATIONS OF ORGANIC COMPOUNDS
EP2340820A1 (en) 2009-12-16 2011-07-06 KRKA, tovarna zdravil, d.d., Novo mesto Moisture-activated granulation process
EP2216020A1 (en) 2009-02-05 2010-08-11 KRKA, tovarna zdravil, d.d., Novo mesto Moisture-activated granulation process
EA201190091A1 (en) 2009-02-05 2012-01-30 Крка, Товарна Здравил, Д. Д., Ново Место ACTIVATED MOISTURE GRANULATION METHOD
TR201002256A1 (en) * 2010-03-24 2011-10-21 Sanovel �La� Sanay� Ve T�Caret Anon�M ��Rket� Stable aliskiren formulations
US20110268797A1 (en) * 2010-04-30 2011-11-03 Sanovel IIac Sanayi Ve Ticaret Anonim Sirketi Multicoated aliskiren formulations
CN106620644B (en) * 2016-12-13 2021-05-25 杭州新诺华医药有限公司 Stable perindopril indapamide tablet and preparation process thereof

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0678503A1 (en) * 1994-04-18 1995-10-25 Ciba-Geigy Ag Delta-amino-gamma-hydroxy-omega-aryl alkanoic acid amides with enzyme especially renin inhibiting activities
WO2003097098A1 (en) * 2002-05-17 2003-11-27 Novartis Ag Pharmaceutical composition comprising a renin inhibitor, a calcium channel blocker and a diuretic
US20050272790A1 (en) * 2004-03-17 2005-12-08 Rigassi-Dietrich Petra G Galenic formulations of organic compounds
WO2005116016A1 (en) * 2004-05-24 2005-12-08 Irm Llc Compounds and compositions as ppar modulators
WO2006029349A1 (en) * 2004-09-09 2006-03-16 Novartis Ag Combination of organic compounds
WO2006041974A1 (en) * 2004-10-08 2006-04-20 Novartis Ag Use of renin inhibitors for the prevention or treatment of diastolic dysfunction or diastolic heart failure
WO2006116435A2 (en) * 2005-04-27 2006-11-02 Novartis Ag Methods of treating atherosclerosis
EP1782859A2 (en) * 2003-04-11 2007-05-09 Novo Nordisk A/S Pharmaceutical use of substituted pyrazolo [1,5- a]pyrimidines

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE9003296L (en) * 1990-10-16 1992-04-17 Kabi Pharmacia Ab PROCEDURE SHOULD FORMULATE MEDICINAL PRODUCTS
US20030114389A1 (en) * 2001-11-13 2003-06-19 Webb Randy Lee Combination of organic compounds
TW200804241A (en) * 2006-02-24 2008-01-16 Novartis Ag New salt

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0678503A1 (en) * 1994-04-18 1995-10-25 Ciba-Geigy Ag Delta-amino-gamma-hydroxy-omega-aryl alkanoic acid amides with enzyme especially renin inhibiting activities
WO2003097098A1 (en) * 2002-05-17 2003-11-27 Novartis Ag Pharmaceutical composition comprising a renin inhibitor, a calcium channel blocker and a diuretic
US20050182042A1 (en) * 2002-05-17 2005-08-18 Feldman David L. Pharmaceutical composition comprising a renin inhibitor, a calcium channel blocker and a diuretic
EP1782859A2 (en) * 2003-04-11 2007-05-09 Novo Nordisk A/S Pharmaceutical use of substituted pyrazolo [1,5- a]pyrimidines
US20050272790A1 (en) * 2004-03-17 2005-12-08 Rigassi-Dietrich Petra G Galenic formulations of organic compounds
US20060018960A1 (en) * 2004-03-17 2006-01-26 Rigassi-Dietrich Petra G Galenic formulations of organic compounds
WO2005116016A1 (en) * 2004-05-24 2005-12-08 Irm Llc Compounds and compositions as ppar modulators
WO2006029349A1 (en) * 2004-09-09 2006-03-16 Novartis Ag Combination of organic compounds
WO2006041974A1 (en) * 2004-10-08 2006-04-20 Novartis Ag Use of renin inhibitors for the prevention or treatment of diastolic dysfunction or diastolic heart failure
WO2006116435A2 (en) * 2005-04-27 2006-11-02 Novartis Ag Methods of treating atherosclerosis

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
See also references of EP2136789A2 *
VILLAMIL, A. ET AL: "Renin inhibition with aliskiren provides additive antihypertensive efficacy when used in combination with hydrochlorothiazide", J. HYPERTENS., vol. 25, January 2007 (2007-01-01), pages 217 - 226, XP002435254 *

Also Published As

Publication number Publication date
EP1972335A1 (en) 2008-09-24
UA96622C2 (en) 2011-11-25
EA020331B1 (en) 2014-10-30
EA200901146A1 (en) 2009-12-30
WO2008116601A2 (en) 2008-10-02
WO2008116601A4 (en) 2009-09-24
US20100143460A1 (en) 2010-06-10
EP2136789A2 (en) 2009-12-30

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